EXPERIMENTAL SUBJECTS & RESEARCH ETHICS ANTH 3301: HEALTH, HEALING & ETHICS PROF. SMITH-MORRIS

Informed Consent Process

IRB REVIEW Institutional Review Board (IRB): A campus-wide committee charged with the review of human participants research to assure that the rights and welfare of human participants are adequately protected. Why do we need IRB review? No one can be objective about their own work People underestimate the risks involved in things they are very familiar with People overestimate the benefit of things that are important to them

DEFINITIONS Research - a systematic investigation designed to develop or contribute to generalizable knowledge. Human Subject - a living individual about whom an investigator conducting research obtains data through intervention or interaction with the individual, or identifiable private information

ETHICAL CHALLENGES IN CROSS-CULTURAL HEALTH CARE Sensitive Research Topics Circumcision and Infibulation (Greenbaum) Transplant and Sale of Organs (Scheper-Hughes, Cohen) Child Circulation (Leinaweaver) End of Life Common Morality and Universals in Health Care Participant Observation Observation vs. Participation Overt vs. Covert (“more likely to provide detailed portraits of contextualized social realities”, Li 2008: 101) Vulnerability of the Researched Plasticity of Field Membership Roles

INVESTIGATOR RESPONSIBILITY #1 Design And Implement Ethical Research, Consistent With Three Ethical Principles Delineated In The Belmont Report: Respect for Persons Individual autonomy Protection of individuals with reduced autonomy Beneficence Maximize benefits and minimize harms Justice Equitable distribution of research costs and benefits

INVESTIGATOR RESPONSIBILITY #2 Comply With All Applicable Federal Regulations Impacting The Protection Of Human Subjects

INVESTIGATOR RESPONSIBILITY #3 Ensure That All Research Involving Human Subjects Is Submitted To And Approved By The Appropriate Institutional Review Board

INVESTIGATOR RESPONSIBILITY #4 Comply With All Applicable IRB Policies, Procedures, Decisions, Conditions, And Requirements

IRB DECISION MATRIX BENEFICENCE JUSTICE RESPECT FOR PERSONS Privacy & Confidentiality Protection of subjects (especially vulnerable populations) Informed consent Surrogate consent Assent Risk/Benefit Analysis Experimental Design Qualifications of PI Subject selection Inclusion/exclusion Recruitment J. Cooper, Albany Medical Center

INVESTIGATOR RESPONSIBILITY #5 Implement Research As Approved And Obtain Prior IRB Approval For Changes

INVESTIGATOR RESPONSIBILITY #6 Obtain Informed Consent and Assent In Accord With Federal Regulations And As Approved By The IRB

THE CONSENT PROCESS Informed consent is not a single event or just a form to be signed -- rather, it is an educational process that takes place between the investigator and the prospective subject. The basic elements of the consent process include: full disclosure of the nature of the research and the subject's participation, adequate comprehension on the part of the potential subjects, and the subject's voluntary choice to participate.

INVESTIGATOR RESPONSIBILITY #7 Document Informed Consent and Assent In Accord With Federal Regulations And As Approved by the IRB

DOCUMENTATION OF CONSENT Articles in most popular magazines are at the 8th grade level. Factors that improve readability include the following: Technical terms should be replaced with ordinary language; Use active tense rather than passive tense verbs ("We did" rather than "It was done"); Write shorter sentences in general; and Make clear the links of logical sequences and of cause-and- effect, even if doing so makes the sentence much longer. ("We will do this, because that happened".)

INVESTIGATOR RESPONSIBILITY #8 Report Progress Of Approved Research To The IRB, As Often And In The Manner Prescribed By The IRB

INVESTIGATOR RESPONSIBILITY #9 Report To The IRB Any Injuries, Adverse Events, Or Other Unanticipated Problems Involving Risks To Subjects Or Others

INVESTIGATOR RESPONSIBILITY #10 Retain Signed Consent Documents And IRB Research Records For At Least Three Years Past Completion Of The Research Activity

Drug Seeding "Trial" for Advertising Boghuma Kabisen Titanji

WHAT IS PEER REVIEW? A system for assessing the quality of research – including validity, significance, and originality – before it is published. Validity – claims are well-justified based on data that were gathered or analyzed. Significance – claims convey real meaning, whether statistical significance or importance to the subject area Originality – data or claims are new, innovative, and independent

HOW TO DETERMINE IF A JOURNAL IS PEER-REVIEWED? 1.Only original research is peer-reviewed; 1.Not opinion, editorial, or book reviews. 2.Not news items or announcements. 2.Read the stated journal policy in: 1.Front or Back Matter of the journal itself 2.Online at the journal’s homepage 3.Online at the journal’s “Instructions to Authors” section or other pages 4.Sometimes they will thank the anonymous reviewers in their Acknowledgements. Only anonymous reviewers indicate a peer review process – named colleagues do not offer official peer review.

CASES Singer “Medical Papers by Ghostwriters” Moral Dilemmas:Truth-Telling/Conveyance Beneficence Professional Ethics (peer review) Integrity, Conscientiousness Altman “Hospital Errors” Moral Dilemmas:Non-Maleficence/Neglect Do Not Kill/Cause Pain or Suffering Conscientiousness Moral vs. Legal Responsibility Gawande “A Lifesaving Checklist” Moral Dilemmas:Beneficence/Non-Maleficence Professional Ethics (IRB protocol) Integrity, Conscientiousness Moral vs. Legal Responsibility

UPCOMING ASSIGNMENTS Mid-Term Exam (Friday 17 th ) Review sheet and discussion Thursday (also see online resources) News Log (due Monday 20 th ) Identify the moral dilemma(s) first, then provide specification. Limit personal opinion. Double-spaced; a critical essay (not one article per page; see Writing Guidelines) Illness Narrative (due Monday Aug.3 rd ) Interview of a family member about an illness experience